CYTK Cytokinetics Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 08, 2024

 

 

Cytokinetics, Incorporated

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			000-50633	94-3291317
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
350 Oyster Point Boulevard
South San Francisco, California				94080
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 624-3000

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		CYTK		The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

---

Item 2.02 Results of Operations and Financial Condition.

On August 8, 2024, Cytokinetics, Incorporated announced its financial results for the second quarter ended June 30, 2024. The full text of the press release issued in connection with this announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished under this Item 2.02 and under Exhibit 99.1 shall not be considered “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Registrant expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.

Item 9.01 Financial Statements and Exhibits.

(d)

 

99.1 Press Release dated August 8, 2024

104 The cover page of this report has been formatted in Inline XBRL

---

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			CYTOKINETICS, INCORPORATED
Date:	August 8, 2024	By:	/s/ John O. Faurescu
			John O. Faurescu, Esq., Vice President, Associate General Counsel & Secretary

 

---

 

 

 

 

 

CYTOKINETICS REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS

 

Type B Meeting Held with FDA Related to Potential Risk Mitigation Strategies for Aficamten;

Company Has Initiated Rolling NDA Submission

 

FDA Cleared Protocol Amendment for FOREST-HCM Reducing Frequency of

Echocardiographic Monitoring Required During Maintenance Treatment

 

~$1.4 Billion in Cash, Cash Equivalents and Investments as of June 30, 2024

 

SOUTH SAN FRANCISCO, Calif., Aug. 8, 2024 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the second quarter of 2024.

 

“Cytokinetics made substantial progress during the second quarter across our pipeline and aligned to near-term goals as well as our longer-term vision to build a sustainable specialty cardiology business. In May, we secured contingent access to more than $1 billion in funding to support the potential global launch of aficamten as well as to continue conduct of label-expanding clinical trials of aficamten worldwide and to advance our later-stage pipeline including omecamtiv mecarbil and CK-586,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “These three programs, anchored in our pioneering science of myosin modulation provide synergistic opportunities in adjacent specialty cardiology indications that we believe will unlock shareholder value while making good on our promise to patients.”

 

Q2 and Recent Highlights

 

Cardiac Muscle Programs

 

aficamten (cardiac myosin inhibitor)

 

---

 

 

 

 

 

 

 

 

 

---

 

 

 

 

 

 

 

 

omecamtiv mecarbil (cardiac myosin activator)

 

 

 

CK-4021586 (CK-586, cardiac myosin inhibitor)

 

---

 

CK-3828136 (CK-136, cardiac troponin activator)

 

 

Pre-Clinical Development and Ongoing Research

 

 

Corporate

 

 

Second Quarter 2024 Financial Results

 

Cash, Cash Equivalents and Investments

 

As of June 30, 2024, the company had approximately $1.4 billion in cash, cash equivalents and investments compared to $634.3 million at March 31, 2024. In the second quarter, the company completed a public offering of 11,274,510 shares of its common stock which included the underwriters’ exercise in full of their option to purchase additional shares, raising approximately $563.2 million in net proceeds, after deducting underwriting discounts and commissions. On May 22, 2024, the company entered into a strategic funding collaboration with Royalty Pharma totaling up to $575 million to support the commercialization of aficamten and to advance the company’s expanding cardiovascular pipeline as the company advances its muscle biology-directed specialty cardiology business. The company received $250 million upon execution, including $100 million to fund a confirmatory Phase 3 trial of omecamtiv mecarbil, $50 million to fund a proof-of-concept Phase 2a clinical trial for CK-586, $50 million term loan to support the potential commercial launch of aficamten in obstructive HCM, and $50 million from the purchase of Cytokinetics’ common stock in a private placement. Under the terms of the collaboration, the company, at its option, can borrow up to $175 million upon satisfaction of certain conditions and receive up to $150 million investment in a Phase 3 clinical trial of CK-586 subject to Royalty Pharma exercising its option to participate in the funding of such a trial in exchange for an additional revenue interest in the net sales of CK-586.

 

Revenues

 

---

 

Research and Development (R&D) Expenses

 

 

General and Administrative (G&A) Expenses

 

 

Net Income (Loss)

 

 

2024 Financial Guidance

 

The company is updating its full year 2024 financial guidance:

 

	Current Guidance	Previous Guidance
GAAP Operating Expense[1]	$555m to $575m	$535m to $555m
Non-cash Expense[2] Included in GAAP Operating Expense	$110m to $105m	$115m to $105m
Non-GAAP Operating Expense[3]	$445m to $470m	$420m to $450m
Net Cash Utilization[4]	$400m to $420m	$390m to $420m

 

The financial guidance does not include the effect of GAAP adjustments caused by events that may occur subsequent to the publication of this guidance including but not limited to business development activities.

 

[1]GAAP operating expense comprised of R&D and G&A expenses.

[2]Non-cash operating expense comprised of stock-based compensation and depreciation.

[3]Non-GAAP operating expense comprised of R&D and G&A expenses but excludes non-cash operating expense.

[4]Net cash utilization is a non-GAAP financial measure that we define as our ending 2023 cash, cash equivalents, and investments balance of $655 million plus the net proceeds of $707 million received from the sale of common stock (through the at-the-market facility, public offerings, and stock purchase agreement with Royalty Pharma) plus proceeds of $200 million received from the structured financing

---

agreement with Royalty Pharma announced on May 22, 2024 minus our projected ending 2024 cash, cash equivalents, and investments balance of between $1,142 million and $1,162 million.

 

Conference Call and Webcast Information

 

Members of Cytokinetics’ senior management team will review the company’s second quarter 2024 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by registering in advance at the following link: Cytokinetics Q2 2024 Earnings Conference Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call. An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.

 

About Cytokinetics

 

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy which were published in the New England Journal of Medicine. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF

 

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

 

Forward-Looking Statements

 

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, or more specifically, our ability to file a new drug application for aficamten in the United States in the third quarter of 2024 or a marketing authorisation application for

---

aficamten in the European Union in the fourth quarter of 2024, our ability to complete enrollment of MAPLE-HCM in the third quarter of 2024, our ability to complete enrollment of ACACIA-HCM in 2025, our ability to start a new Phase 3 confirmatory trial of omecamtiv mecarbil in the fourth quarter of 2024, and to commence a Phase 2a study of CK-586, if ever, the timing of interactions with FDA or any other regulatory authorities in connection to any of our drug candidates and the outcomes of such interactions; statements relating to the potential patient population who could benefit from aficamten, omecamtiv mecarbil, CK-586, CK-136 or any of our other drug candidates; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Ji Xing; statements relating to our operating expenses or cash utilization for the remainder of 2024, and statements relating to our cash balance at year-end 2024 or any other particular date or the amount of cash runway such cash balances represent at any particular time. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year 2023. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

 

CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

 

###

 

Contact:

Cytokinetics

Diane Weiser

Senior Vice President, Corporate Affairs

(415) 290-7757

---

 

 

 

Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)
		June 30, 2024		December 31, 2023
		(unaudited)
ASSETS
Current assets:
Cash and short term investments		$ 1,056,775		$ 614,824
Other current assets		11,035		13,227
Total current assets		1,067,810		628,051
Long-term investments		305,361		40,534
Property and equipment, net		65,689		68,748
Operating lease right-of-use assets		77,249		78,987
Other assets		7,679		7,996
Total assets		$ 1,523,788		$ 824,316
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable and accrued liabilities		$ 49,283		$ 64,148
Short-term operating lease liabilities		18,507		17,891
Current portion of long-term debt		11,520		10,080
Derivative liabilities measured at fair value		13,200		—
Other current liabilities		10,267		10,559
Total current liabilities		102,777		102,678
Term loan, net		92,831		58,384
Convertible notes, net		550,600		548,989
Liabilities related to revenue participation right purchase agreements, net		435,112		379,975
Long-term operating lease liabilities		116,718		120,427
Liabilities related to RPI Transactions measured at fair value		117,200		—
Other non-current liabilities		—		186
Total liabilities		1,415,238		1,210,639
Commitments and contingencies
Stockholders’ equity (deficit):
Common stock		117		102
Additional paid-in capital		2,500,654		1,725,823
Accumulated other comprehensive loss		(1,022)		(10)
Accumulated deficit		(2,391,199)		(2,112,238)
Total stockholders’ equity (deficit)		108,550		(386,323)
Total liabilities and stockholders’ equity (deficit)		$ 1,523,788		$ 824,316

 

 

 

 

---

 

 

 

Cytokinetics, Incorporated
Condensed Consolidated Statements of Operations
(in thousands except per share data)
(unaudited)
		Three Months Ended
		June 30, 2024		June 30, 2023
Revenues:
Research and development revenues		$ 249		$ 867
Milestone revenues		—		—
Total revenues		249		867
Operating expenses:
Research and development		79,597		83,194
General and administrative		50,824		39,722
Total operating expenses		130,421		122,916
Operating loss		(130,172)		(122,049)
Interest expense		(12,732)		(7,045)
Non-cash interest expense on liabilities related to revenue participation right purchase agreements		(11,567)		(6,322)
Interest and other income, net		11,553		6,779
Change in fair value of derivative liabilities		(600)		—
Change in fair value of liabilities related to RPI Transactions		200		—
Net loss		$ (143,318)		$ (128,637)
Net loss per share — basic and diluted		$ (1.31)		$ (1.34)
Weighted-average number of shares used in computing net loss per share — basic and diluted		109,240		95,755

 

---

v3.24.2.u1

Document And Entity Information	Aug. 08, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 08, 2024
Entity Registrant Name	Cytokinetics, Incorporated
Entity Central Index Key	0001061983
Entity Emerging Growth Company	false
Entity File Number	000-50633
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	94-3291317
Entity Address, Address Line One	350 Oyster Point Boulevard
Entity Address, City or Town	South San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94080
City Area Code	(650)
Local Phone Number	624-3000
Entity Information, Former Legal or Registered Name	N/A
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	CYTK
Security Exchange Name	NASDAQ

---